A Longitudinal Outcomes Study of the Subchondroplasty® Procedure in the Hip
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Subchondral Cysts
- 发起方
- Zimmer Biomet
- 入组人数
- 77
- 试验地点
- 12
- 主要终点
- Change in Modified Harris Hip Score (mHHS) from baseline at 12 months
- 状态
- 已完成
- 最后更新
- 11天前
概览
简要总结
Post-market clinical outcomes study to collect data on the short- and long-term outcomes for subjects who are undergoing or have undergone the Subchondroplasty® (SCP®) Procedure in the hip in a standard clinical setting. Outcomes to be assessed include medication usage, pain, function, activity levels and patient satisfaction.
详细描述
This study is designed as a post-market, single arm, non-randomized multi-center investigation. Male and female subjects, at least 18 years of age, with at least one subchondral bone defect in the form of a cyst and/or bone marrow lesion (BML), insufficiency fracture or bone defect associated with early stage avascular osteonecrosis (AVN) in the femoral head, femoral neck and/or acetabulum who are suitable candidates for use of AccuFill during the Subchondroplasty Procedure are eligible for enrollment in this study. A maximum of 15 study sites, in the United States of America, will enroll a target of 50 subjects. Each Investigator must obtain IRB approval, or favorable opinion by an EC, prior to consent of the first subject; no study-related procedures can occur without the approval and oversight of a registered IRB or EC. If the study site does not have an IRB of record, a central IRB may be utilized upon approval by Zimmer Biomet. Demographics, medical history, hip history and use of pain medication and therapy will be recorded at the time of subject consent. Additionally, patient reported outcomes measures will be obtained pre-operatively. Operative details including the SCP Procedure, concomitant surgical procedures and intraoperative safety events will be recorded at the time of surgery. Prospective subjects will be considered enrolled in this study once their Subchondroplasty Procedure has been performed. Subjects will complete only the Numeric Pain Scale at 2 weeks post-operatively. Thereafter, subjects will complete self-reported outcomes measures post-operatively at 6 weeks, 12 weeks, 6 months, 1 year and 2 years. These measures include information on pain medication and therapy, pain levels, function, activity and subject satisfaction. Screening for adverse events and conversion will occur throughout the study. Subjects will complete the study at 2 years or will be withdrawn if they undergo conversion of the Subchondroplasty site. For the purposes of this protocol, a conversion will be defined as total hip arthroplasty or any procedure involving removal of the AccuFill material on the index hip.
研究者
入排标准
入选标准
- •Candidates must meet ALL of the following:
- •Surgeon considers the patient appropriate for the SCP Procedure of the hip.
- •Subchondral bone defect(s) in the femoral head, femoral neck and/or acetabulum has been confirmed via radiographic finding on MRI or x-ray.
- •Subject provides voluntary signature on the IRB approved Informed Consent Form.
- •Subject is at least 18 years of age.
- •Subject must be physically and mentally willing and able, in the Investigator's opinion at the time of enrollment, to be compliant with the protocol and complete outcome forms via email, telephone, in-person or by regular mail.
排除标准
- •Candidates will be excluded if they meet ANY of the following:
- •Subject has collapse of subchondral bone.
- •Subject is pregnant at the time of surgery.
- •Subject is incarcerated.
- •Subject is involved in active litigation related to the condition being treated.
- •Subject is not comfortable with speaking, reading, and understanding questions and providing responses in an available language for the PROs in the protocol.
结局指标
主要结局
Change in Modified Harris Hip Score (mHHS) from baseline at 12 months
时间窗: 12 months
Change in Modified Harris Hip Score using a 0-100 overall score, from baseline at 12 months. Subscales of pain, function, and activity levels are combined to generate the overall score. Pain is scored out of 44 possible points, function is scored out of 33 possible points and subject activities are scored out of 14 possible points. The maximum score of 91 is multiplied by 1.1 to give a total score out of 100; a higher score represents better patient reported pain, function and activity levels.
Overall Group Mean Improvement From Baseline of the Modified Harris Hip Score (mHHS) at 2 Years
时间窗: 2 Years
Change in Modified Harris Hip Score using a 0-100 overall score, from baseline at 2-years. Subscales of pain, function, and activity levels are combined to generate the overall score. Pain is scored out of 44 possible points, function is scored out of 33 possible points and subject activities are scored out of 14 possible points. The maximum score of 91 is multiplied by 1.1 to give a total score out of 100; a higher score represents better patient reported pain, function and activity levels.
次要结局
- Change in Hip Outcome Score from baseline at 12 months(12 months)
- Change in numeric pain score from baseline at 12 months(12 months)
- Incidence and severity of device and/or procedure related adverse events and surgical conversions(2 years)
- Change in EuroQol-5 Dimensions (EQ-5D) from baseline at 12 months(12 months)
- Pain and Functional Performance by Numeric Pain Scale (NPS)(2 weeks postoperative)
- Pain and Functional Performance by Numeric Pain Scale (NPS)(6 weeks postoperative)
- Pain and Functional Performance by Numeric Pain Scale (NPS)(12 weeks postoperative)
- Pain and Functional Performance by Numeric Pain Scale (NPS)(6 months postoperative)
- Pain and Functional Performance by Numeric Pain Scale (NPS)(1 year postoperative)
- Pain and Functional Performance by Numeric Pain Scale (NPS)(2 years postoperative)
- Modified Harris Hip Score (mHHS)(6 weeks postoperative)
- Modified Harris Hip Score (mHHS)(12 weeks postoperative)
- Modified Harris Hip Score (mHHS)(6 months postoperative)
- Modified Harris Hip Score (mHHS)(1 year postoperative)
- Modified Harris Hip Score (mHHS)(2 years postoperative)
- Subject Quality-of-life Measured by the EQ-5D-5L Score(6 weeks)
- Subject Quality-of-life Measured by the EQ-5D-5L Score(12 weeks)
- Subject Quality-Of-Life Measured by the EQ-5D-5L Visual Analog Scale (VAS)(6 Months)
- Subject Quality-of-life Measured by the EQ-5D-5L Score(6 months)
- Subject Quality-of-life Measured by the EQ-5D-5L Score(1 Year)
- Subject Quality-of-life Measured by the EQ-5D-5L Score(2 Years)
- Subject Quality-Of-Life Measured by the EQ-5D-5L Visual Analog Scale (VAS)(6 Weeks)
- Subject Quality-Of-Life Measured by the EQ-5D-5L Visual Analog Scale (VAS)(12 Weeks)
- Subject Quality-Of-Life Measured by the EQ-5D-5L Visual Analog Scale (VAS)(1 Year)
- Subject Quality-Of-Life Measured by the EQ-5D-5L Visual Analog Scale (VAS)(2 Years)